Senior Clinical Data Manager - Data Standards

About the role

ICON Strategic Solutions is hiring a Senior Clinical Data Manager focused on Data Standards in Johannesburg. Working in a sponsor-dedicated model, you will lead the development and implementation of clinical data standards processes that support high-quality data delivery across global clinical trials. You will drive data quality, standards development, data review and continuous improvement, partnering with cross-functional stakeholders across the clinical development lifecycle.

Key responsibilities

• Lead the development and operationalisation of clinical data standards processes and best practices.
• Drive initiatives on data cleaning, data quality, edit checks, data listings and standards library management.
• Partner closely with Clinical Trial Reporting (CTR), Clinical Trial Configuration (CTC) and Cross-Functional Data Review (CFDR) teams.
• Establish governance, workflows and quality standards to support clinical trial delivery.
• Lead and mentor Associate Manager-level team members and foster a culture of continuous improvement.
• Translate strategic objectives into operational execution with cross-functional stakeholders.
• Identify risks, drive process improvements and promote data quality across the clinical data lifecycle.

Required profile

• Bachelor's degree in Life Sciences, Health Sciences or a related discipline.
• Extensive Clinical Data Management experience within a CRO, biotechnology or pharmaceutical environment.
• Experience in data quality, standards development, data review, edit checks, data listings or standards library management.
• Proven ability to build and operationalise new processes and ways of working.
• Legal right to work in the country where the role is based.

Required skills

• Strong understanding of clinical trial processes, regulatory requirements and ICH-GCP.
• Process development, project management, stakeholder engagement and cross-functional collaboration.
• Excellent communication, problem-solving and leadership skills.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and learning and development opportunities.